Ignite Creation Date:
2025-12-24 @ 1:48 PM
Ignite Modification Date:
2026-01-03 @ 11:05 PM
Study NCT ID:
NCT02402595
Status:
COMPLETED
Last Update Posted:
2017-03-20
First Post:
2015-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug Interaction Study Between AVP-923 and Itraconazole and Between AVP-786 and Itraconazole in Healthy Adult Subejcts
Sponsor:
Avanir Pharmaceuticals
Organization:
Study Overview
Official Title:
A Phase 1, Single-center, Randomized, Double-blind, Double-dummy, Drug Interaction Study Between AVP-923 and Itraconazole, and Between AVP-786 and Itraconazole in Healthy Adult Subjects
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DDI
Brief Summary:
The purpose of this study is to determine the effects of a potent CYP3A4 inhibitor, itraconazole, on the steady-state PK of AVP-923 and AVP-786.
Detailed Description:
A Phase 1, single-center, randomized, double-blind, double-dummy drug interaction study.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: